MAUDE Adverse Event Report: COOK INC ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant products: lunderquist wires, indy snare, zbis, zisl's, amplatz 1 cm tip stiff wire, glide wires, hnbr catheters, coda balloon, atrium v12 balloon expandable covered stent, esbe-28-39-zt used during the procedure.(b)(6).(b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
On (b)(6) 2019, an endovascular aortic aneurysm repair (evar) procedure was being performed, in which the user would place the "iliac branch device on right, occlude left internal iliac and extend into external iliac on left." the procedure went well, but the final angiogram showed a "leak with evident blush at the proximal edge of the aneurysm sac" on the zenith flex aaa endovascular graft bifurcated main body.The physician re-ballooned the graft with a 32 mm coda balloon, and "a 60 cc / 60 ml syringe with lure lock was used with 10 ml of contrast, and 20 ml of saline".The ballooning was done in the "proximal sealing stent which meant the balloon protruded into the second covered stent, leg overlaps into main body, [and the] distal seals", but the leak continued.The physician then deployed an esbe-28-39-zt over the area of the leak, thinking there may be a fabric tear or hole in the graft.After the esbe was deployed, the "blush" was no longer evident, which confirmed the physician's suspicions of a type iii endoleak.The physician acknowledged the circumferential calcification in the neck could have contributed to the issue.The pre-op cta and intra-op angiograms will be returned and reviewed.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurence.
Event or Problem Description
No additional patient/event details have been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unchanged, unknown or unavailable.H6 - method code: device not accessible for testing (4117).Investigation ¿ evaluation: the complainant, (b)(6) hospital located in australia, informed cook on (b)(6) 2019 of an incident involving a zenith flex aaa endovascular graft bifurcated main body with rpn tffb-26-125-zt from lot 8671321.An endovascular aortic repair (evar) was completed on (b)(6) 2019 for a 90-year-old male patient that had been diagnosed with an abdominal aortic aneurysm and bilateral common iliac aneurysms.Several cook devices including a main body, multiple iliac leg grafts, and an iliac bifurcation graft, were implanted.The initial evar procedure seemed to go smoothly up until the final angiography was completed.At that time, the angiography showed a leak with evident blush at the proximal edge of the aneurysm sac.A 32 mm coda balloon was used in the procedure and ballooning was completed in the proximal sealing stent, leg overlaps into the main body and the distal seals, but the leak continued.The physician deployed a main body extension graft over the area where leaking seemed to be present.The physician thought that there may be a fabric tear or hole in the graft.The final angiography run after the esbe was deployed showed the leak was resolved.At this point, the physician concluded that he was correct and there had been a type 3b endoleak within the graft.The physician also acknowledged that the circumferential calcification in the neck could have contributed to the type 3b endoleak.A review of the complaint history, device history record, drawing, instructions for use (ifu), quality control and specifications, as well as a review of imaging provided was conducted during the investigation.The complaint device was not returned, however imaging was provided and sent for expert review.An endoleak was confirmed, however the specific type of endoleak could not be confirmed.The image reviewer observed that a large type 3b endoleak through a pre-existing fabric defect was not possible based on the procedural angiography.The image reviewer notes that forceful balloon angioplasty likely occurred and could have stretched a suture hole, leading to a type 3b endoleak.However, they also note that a type 1a endoleak is more likely due to severe calcification.Either a type 1a or a type 3b endoleak could have been covered/sealed by the esbe placement, therefore the specific type of endoleak is unable to be determined.Based on the evidence provided and observed, cook has concluded that product was manufactured to current specifications.Additionally, a document based investigation evaluation was performed.A review of the device master record found that sufficient controls and inspections are in place to prevent the release of nonconforming product related to the reported failure mode.A review of the design history file found that the risks associated with the devices are acceptable when weighed against the benefits.A review of the device history record found no nonconformances or additional complaints associated with this device lot.There is no evidence to suggest there is any nonconforming product in house or out in the field.A review of the product labeling for the device was completed.The instructions for use state the following instructions related to the reported failure mode: warnings and precautions; general; additional endovascular interventions or conversion to standard open surgical repair following initial endovascular repair should be considered for patients experiencing an enlarging aneurysm, unacceptable decrease in fixation length (vessel and component overlap) and/or endoleak.An increase in aneurysm size and/or persistent endoleak or migration may lead to aneurysm rupture.; patient selection, treatment and follow-up; the zenith flex aaa endovascular graft is designed to treat aortic neck diameters no smaller than 18 mm and no larger than 32 mm.The zenith flex aaa endovascular graft is designed to treat proximal aortic necks (distal to the lowest renal artery) of at least 15 mm in length.Iliac artery distal fixation site greater than 10 mm in length and 7.5 ¿ 20 mm in diameter (measured outer wall to outer wall) is required.These sizing measurements are critical to the performance of the endovascular repair.; key anatomical elements that may affect successful exclusion of the aneurysm include severe proximal neck angulation (>60 degrees for infrarenal neck to axis of aaa or >45 degrees for suprarenal neck relative to the immediate infrarenal neck); short proximal aortic neck (<15 mm); an inverted funnel shape (greater than 10% increase in diameter over 15 mm of proximal aortic neck length); and circumferential thrombus and/or calcification at the arterial implantation sites, specifically the proximal aortic neck and distal iliac artery interface.In the presence of anatomical limitations, a longer neck may be required to obtain adequate sealing and fixation.Irregular calcification and/or plaque may compromise the attachment and sealing at the fixation sites.Necks exhibiting these key anatomical elements may be more conducive to graft migration or endoleak.; implant procedure; inaccurate placement and/or incomplete sealing of the zenith flex aaa endovascular graft within the vessel may result in increased risk of endoleak, migration or inadvertent occlusion of the renal or internal iliac arteries.Renal artery patency must be maintained to prevent/reduce the risk of renal failure and subsequent complications.; molding balloon use; use care in inflating the balloon within the graft in the presence of calcification, as excessive inflation may cause damage to the vessel.Adverse events; potential adverse events adverse events that may occur and/or require intervention include, but are not limited to:endoleak; endoprosthesis: puncture.Patient counseling information: device-related risks include occlusion, endoleak, aneurysm enlargement, fracture, potential for reintervention and open surgical conversion, rupture and death.Directions for use: pre-implant determinants verify from pre-implant planning that the correct device has been selected.Determinants include: consider the degree of vascular calcification.Bifurcated system; molding balloon insertion; expand the molding balloon with diluted contrast media (as directed by the manufacturer) in the area of the most proximal covered stent and the infrarenal neck, starting proximally and working in the distal direction.; withdraw the molding balloon to the ipsilateral limb overlap and expand.; withdraw the molding balloon to the ipsilateral distal fixation site and expand; deflate and remove molding balloon.Transfer the molding balloon onto the contralateral wire guide and into the contralateral iliac leg introduction system.Advance molding balloon to the contralateral limb overlap and expand.; withdraw the molding balloon to the contralateral iliac leg/vessel distal fixation and expand.Imaging guidelines and postoperative follow-up: general; the long-term performance of endovascular grafts has not yet been established.All patients should be advised that endovascular treatment requires lifelong, regular follow-up to assess their health and performance of their endovascular graft.Patients with specific clinical findings (e.G., endoleaks, enlarging aneurysms or changes in the structure or position of the endovascular graft) should receive additional follow-up.Patients should be counseled on the importance of adhering to the follow-up schedule, both during the first year and at yearly intervals thereafter.Patients should be told that regular and consistent follow-up is a critical part of ensuring the ongoing safety and effectiveness of endovascular treatment of aaas.; additional surveillance and treatment additional surveillance and possible treatment is recommended for: aneurysms with type i endoleak; aneurysms with type iii endoleak.Based on the information provided, inspection of the product, and the results of the investigation, a definitive cause was established as adverse event related to patient condition and unintended use error.It is possible that during the balloon angioplasty, which increased the neck lumen diameter by 5mm, a suture hole on the graft was stretched.It is also possible that the patient¿s severe calcification, in combination with the balloon angioplasty, damaged the graft and caused a minor puncture.Additionally, endoleaks are a known inherent risk of these devices.The appropriate personnel have been notified.Per the quality engineering risk assessment, no further action is required.Cook will continue to monitor for similar complaints.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• Brand Name: ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY
• Common Device Name: MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9153006
• Report Number: 1820334-2019-02530
• Device Sequence Number: 13909473
• Product Code: MIH
• UDI-Device Identifier: 10827002484150
• UDI-Public: (01)10827002484150(17)200326(10)8671321
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: P020018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/26/2020
• Device Model Number: N/A
• Device Catalogue Number: TFFB-26-125-ZT
• Device Lot Number: 8671321
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/19/2019
• Supplement Date Received by Manufacturer: 04/10/2020
• Initial Report FDA Received Date: 10/03/2019
• Supplement Report FDA Received Date: 04/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention